Public Citizen has filed a recall petition with the Food and Drug Administration (FDA) for Aricept 23 milligram, claiming that the higher dose is too dangerous for the drug's largely unproven effectiveness.
Aricept (donepezil) is a prescription medication that was approved for the treatment of Alzheimer's disease in 1996. Previously only lower doses of 5 to 10 mg of the drug were used. The 23 mg Aricept was approved by the FDA in 2010, although an FDA medical reviewer and an FDA statistical reviewer objected to its approval.
According to Public Citizen, the side effects of Aricept in the 23 mg dose are much more severe than at lower doses and may include lowered pulse, nausea or vomiting, diarrhea, urinary incontinence, dizziness, fatigue, anorexia, agitation, and confusion. The repeated vomiting can lead to pneumonia, gastrointestinal bleeding, esophageal rupture, and death, particularly in elderly people with Alzheimer's disease.
To date only one clinical trial for 23 mg Aricept has been submitted to the FDA, and according to Public Citizen, it failed to show that the 23 mg version is more effective than the lower dosage amounts.
This has not been Public Citizen's first petition to the FDA to remove a prescription medication. In 2006, the group wanted the FDA to remove the painkillers Darvon and Darvocet. The FDA removed both medications in November 2010, agreeing that the medications only provide minimal pain relief and increase the risk of heart failure and serious heart-related problems.